BEUDAMED
    FDA Recall Terminated

    Torque Limiting Adaptor, AO Connect, 4 N-m, part #027-203, reusable, a component of the Bodycad Fine Osteotomy Implant and Disposable Instrumentation Tray, part #025-004.

    Recall: Z-0244-2022 · Initiated July 2, 2021

    Recall

    Recall Number
    Z-0244-2022
    Event Number
    88878
    Firm
    Laboratoires Bodycad, Inc.
    FEI Number
    3012086398
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 2, 2021
    Terminated
    January 4, 2023
    Address
    2035 Du Haut-Bord St, Quebec Canada

    Description

    Torque Limiting Adaptor, AO Connect, 4 N-m, part #027-203, reusable, a component of the Bodycad Fine Osteotomy Implant and Disposable Instrumentation Tray, part #025-004.

    Reason

    There is a risk of breakage of the torque limiting adaptor if used counterclockwise and it must not be used with a power tool due to no test data validating this use.

    Action

    The recalling firm issued an Advisory Notice Information dated 2020-06-30 on 7/2/2021 via email which explained the reason for recall and that they would be contacted as soon as possible to proceed with the exchange. On 9/24/2021, a Returned Goods Authorization Form was sent to the consignees so the adapter could be exchanged.

    Distribution

    Distribution was made to CO, MI, and NY. Foreign distribution was made to Canada and the United Kingdom. There was no military/government distribution.

    Quantity

    10 in the U.S.